Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-01-04 @ 4:28 AM
Study NCT ID:
NCT05686759
Status:
RECRUITING
Last Update Posted:
2025-06-25
First Post:
2022-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2022-12-02', 'studyFirstSubmitQcDate': '2023-01-09', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events occurred during clinical trials', 'timeFrame': 'during 20 weeks post first Investigational product administration', 'description': 'Safety will be assessed throughout the study through clinical safety evaluations(Adverse events)'}], 'secondaryOutcomes': [{'measure': 'Positive rate of Hepatitis B Surface Antigen(HBsAg)', 'timeFrame': 'Screening, 0, 4, 8, 12, 16, and 20 weeks', 'description': 'Hepatitis B Surface Antigen(HBsAg) will be tested at every visit(V1\\~V7)'}, {'measure': 'Hepatitis B Surface Antibody(Anti HBs) titer', 'timeFrame': 'Screening, 0, 4, 8, 12, 16, and 20 weeks', 'description': 'Hepatitis B Surface Antibody(Anti HBs) titer will be tested at every visit(V1\\~V7)'}, {'measure': 'Positive rate of Hepatitis B e Antigen(HBeAg)', 'timeFrame': 'Screening, 0, 4, 8, 12, 16, and 20 weeks', 'description': 'Hepatitis B e Antigen(HBeAg) will be tested at every visit(V1\\~V7)'}, {'measure': 'Positive rate of Hepatitis B Virus DNA(HBV DNA)', 'timeFrame': 'Screening, 0, 4, 8, 12, 16, and 20 weeks', 'description': 'Hepatitis B Virus DNA(HBV DNA) will be tested at every visit(V1\\~V7)'}, {'measure': 'Laboratory tests', 'timeFrame': 'Screening, 0, 4, 8, 12, 16, and 20 weeks', 'description': 'Change from baseline in safety laboratory tests results (hematology,chemistry, urine) (each visit)'}, {'measure': 'Vital signs', 'timeFrame': 'Screening, 0, 4, 8, 12, 16, and 20 weeks', 'description': 'Change from baseline in vital sign (Blood Pressure, Pulse Rate, Body Temperature) (each visit)'}, {'measure': 'Physical examination', 'timeFrame': 'Screening, 0, 4, 8, 12, 16, and 20 weeks', 'description': 'Change from baseline in physical examination (Appearance, Skin, Head/Neck, Thorax/Lungs etc) (each visit)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatitis B', 'Liver Transplantation', 'Hepatitis B Immunoglobulin', 'Liver Diseases'], 'conditions': ['Hepatitis B']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of undiluted intravenous infusion of I.V.-Hepabig inj. in post-liver transplant patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged ≥18 and \\<65 years at the time of signing the consent form\n2. Subjects who had history of liver transplantation due to HBV-related end-stage liver disease such as cirrhosis, liver cancer and fulminant hepatic failure and received treatment for prevent hepatitis B recurrence\n3. HBsAg(+) before liver transplantation\n4. Subjects who have been received I.V.-Hepabig inj more than 3 times dose of 10,000International Unit/4weeks regimen\n\nExclusion Criteria:\n\n1. Subject with history of anaphylaxis to any component of the investigational product\n2. Pregnant or breast-feeding women\n3. Deficiency of Immunoglobulin A\n4. Clinically significant renal diseases (serum creatinine \\>2.0mg/dL, anuria, renal failure or on dialysis at screening)\n5. Hemophilia\n6. Co-infection with Hepatitis A Virus, Hepatitis C Virus, or Human Immunodeficiency Virus\n7. Subject with history of malignancy within the last 5 years (excluding primary liver cancer)\n8. Subject received estrogen or hormone replacement therapy within 3 months before screening\n9. HBsAg or HBeAg or HBV DNA positive at screening\n10. Anti HBs titer less than below criteria at screening \\<150 IU/L for subject whose HBeAg and HBV DNA were negative(-) before liver transplantation \\>500 IU/L for subject whose HBeAg or HBV DNA were positive(+) before liver transplantation\n11. Subject with history of drug abuse\n12. Participated in another clinical study within 30 days (relative to the last dose of investigational product) before screening\n13. Subject who are determined disqualified to join clinical trials by investigator'}, 'identificationModule': {'nctId': 'NCT05686759', 'briefTitle': 'A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.', 'organization': {'class': 'INDUSTRY', 'fullName': 'GC Biopharma Corp'}, 'officialTitle': 'A Phase 3b Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj. in Post-liver Transplant Patients', 'orgStudyIdInfo': {'id': 'GC5103-003_UDIV_P3b01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Undiluted intravenous infusion of I.V.-Hepabig inj', 'description': 'Undiluted intravenous infusion of I.V.-Hepabig inj 10,000 International Unit within approximately 30 minutes', 'interventionNames': ['Biological: Undiluted I.V.-Hepabig inj(GC5103)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diluted intravenous infusion of I.V.-Hepabig inj', 'description': 'Diluted intravenous infusion of I.V.-Hepabig inj 10,000 International Unit into Dextrose 5% in water within approximately 1 hour', 'interventionNames': ['Biological: Diluted I.V.-Hepabig inj(GC5103)']}], 'interventions': [{'name': 'Undiluted I.V.-Hepabig inj(GC5103)', 'type': 'BIOLOGICAL', 'description': 'undiluted I.V.-Hepabig inj(GC5103) 10,000 International Unit', 'armGroupLabels': ['Undiluted intravenous infusion of I.V.-Hepabig inj']}, {'name': 'Diluted I.V.-Hepabig inj(GC5103)', 'type': 'BIOLOGICAL', 'description': 'Diluted I.V.-Hepabig inj(GC5103) 10,000 International Unit', 'armGroupLabels': ['Diluted intravenous infusion of I.V.-Hepabig inj']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10408', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'National Cancer Center', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'zip': '16499', 'city': 'Suwon', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Ajou University Medical Center', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '05505', 'city': 'Seoul', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '48108', 'city': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Inje University Haeundae Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '35015', 'city': 'Daejeon', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '03080', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jiyoung Sin', 'role': 'CONTACT', 'email': 'jiyoung.sin@gccorp.com', 'phone': '82-(0)31-260-9570'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GC Biopharma Corp', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}